Lord v. HHS, (Fed. Cl. Spec. Mstr. Feb. 9, 2016) (Dorsey, CSM)
This is another case finding that petitioner failed to show preponderant evidence that vaccines are an exogenous stressor for purposes of the Triple Risk Model of SIDS. The petitioner also failed to show that recognized extrinsic risk factors, and URIs in particular, act as neurochemical rather than mechanical risk factors. The Court discussed important similarities and differences between the immune response to infections and an immune response to vaccinations. First, cytokine production in response to vaccination is localized and does not generate significant systemic signaling. An infection, on the other hand, is a live organism that infects a cell directly and has the ability to replicate in the body and cause a significant immune reaction. The vaccines at issue were composed of particulate killed organisms, which, administered alone, would not elicit much of an immune response beyond a local reaction, requiring the addition of an adjuvant.
The Court acknowledged that cytokines are released in response to vaccination. However, petitioner failed to show that cytokines produce an abnormal brainstem serotonin response or otherwise act in a manner that causes or contributes to SIDS. The Court found that the brain regularly produces pro-inflammatory cytokines as part of a normal, regulatory process, which signals the occurrence of a pathologic event and does not themselves cause a pathologic event. Thus, the evidence failed on Althen prong 1.
The court also found that prong 2 was not satisfied because the baby had several known extrinsic risk factors for the Triple Risk Model of SIDS, thus there was no need to consider a speculative risk factor. Petitioners did, however, meet their burden on prong 3.